| Date Initiated by Firm | September 28, 2010 |
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| Date Posted | February 22, 2011 |
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| Recall Status1 |
Terminated 3 on August 11, 2011 |
| Recall Number | Z-1394-2011 |
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| Recall Event ID |
57082 |
| 510(K)Number | K943803 |
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| Product Classification |
Heart Lung Machine - Product Code DTQ
|
| Product | Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20. |
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| Code Information |
Device Part Number (Model Number): 703309 Serial Numbers: 93202512, 93202514, 93202526, 93202527 |
Recalling Firm/
Manufacturer |
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
|
Manufacturer Reason
for Recall | A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function. |
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FDA Determined
Cause 2 | Component change control |
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| Action | Maquet hand delivered a letter to the consignee on 10/4/2010. |
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| Quantity in Commerce | 4 units |
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| Distribution | One hospital in New York City |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = DTQ
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